Statement on the Relationship Between Professional Medical Associations and Industry

This document was reviewed and approved by the Board of Governors of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) in Feb 2010.

Congress and others have called into question the propriety of professional medical associations (PMAs) and industry relationships. [1,2]. These relationships are critical to the continued development of new and better surgical devices and procedures for patients. Moreover, PMAs should work with industry in defined ways to educate physicians about new procedures and devices. Clear guidelines are needed to help structure these relationships. Overly restrictive regulatory oversight risks excessively constraining these relationships, detrimental to medical progress and possibly crippling information dissemination at PMA meetings. Politicians and editors of leading medical journals are advocating for regulation of these interactions to such an extent that these relationships will be severely truncated, and in many cases eliminated entirely. It is true that there have been examples of (financial) relationships between physicians and industry and even PMAs and industry that have been inappropriate, especially where potential conflicts of interest were not revealed or well managed [3,4]. These cases should not be used as the sole basis for excessive regulatory confinement. The involvement of physicians and PMAs with the development and deployment of new drugs, tools, and procedures has been integral to the progress realized by the medical profession in providing safer, higher quality care to patients; this is especially true of the roles surgeons fulfill in the development of medical instruments.

There are several important points that must be highlighted when considering the issue of regulating the relationships between industry and individual physicians or PMAs. They are:

The medical device industry and the pharmaceutical industry are vastly different in their approach to the development of new products.

The medical device development industry is essential to physician innovation and development of new technology

Research and development (R&D) and education must be differentiated and separated from industry sales and marketing.

Full disclosure and complete transparency of physician financial relationships with industry are critical

When considering the involvement of medical professionals in the development of new treatments, it is critical to remember that instrument and procedure development is vastly different from pharmaceutical development.

Pharmaceutical products are often developed by researchers employed directly by the company or through an academic or commercial laboratory, a process often devoid of the practicing physician’s direct involvement. The pharmaceutical company expends considerable in-house resources before the drug is available for potential clinical use. Only after the drug is fully developed does the practicing physician then use the drug in pharmaceutical industry-directed drug trials to establish safety and efficacy. Clinical research involves compensation to the investigators, investigators’ laboratories and their institution that covers direct costs, research overhead, and possibly some surplus (or loss) in return for their participation in such trials. There have been examples by the pharmaceutical industry of focusing on the publication solely of favorable results, although mandatory registration of pharmaceutical trials with www.clinicaltrials.gov will make this less practical. At this point in the life of a new drug, the company has considerable incentive to see the drug reach the market so that they can recover their significant up-front investment, which can range from $800 million to nearly $2 billion per drug [5]. In this setting, there may be an expectation that the physicians’ role is more focused on confirmation of the company’s claims and publication of satisfactory results, and less so on the development or refinement of the drug.

In contrast, a device company rarely develops an instrument with in-house resources alone, but rather relies on individual physicians to bring forward clinical needs and concepts for devices. Physicians often actively participate with in-house engineers (who are not clinicians) to both develop and improve products. For the most part, device companies do not maintain a substantial in-house staff of scientists and researchers but instead they employ engineers who can translate the ideas and needs of practicing physicians into instrument prototypes. Thus the device company’s resources are more heavily leveraged toward identifying and exploring clinical needs as defined by procedure-oriented physicians such as surgeons or endoscopists, and refining prototypes of tools to meet established clinical needs. It is this direct relationship with the physician that allows the development and advancement of medical procedures, often resulting in less invasive procedures that directly benefit patients. Device companies and their engineers cannot and do not independently develop instruments for medical care. This device industry-physician relationship has been essential to the advancement of procedural medicine from the beginning. If this paradigm is legislatively disrupted or destroyed, there will be a significant decline in the number and quality of new products and procedures developed.

Professional medical associations have a particularly important role to play in the process of educating and training physicians in the use of products and performance of procedures As outlined above, device companies cannot and should not develop new tools without defined but close input from practicing physicians. Once a new product is developed and ready for use, there is often considerable education and training needed to safely introduce an instrument or procedure into clinical practice. The physician’s and PMA’s role in education and training is critical and direct physician involvement is needed in designing educational programs, without which a new tool may cause significant harm when introduced into general practice. Continued relationships between PMAs and industry are essential to the continued safe deployment of new medical devices and techniques to the practicing physician.

SAGES physicians are primarily surgeons and other gastrointestinal interventionalists, thus the concepts that guide physician disclosure and transparency guide the conduct of the society as a whole. SAGES postgraduate courses and scientific sessions are constructed solely by physicians (and some allied health members) devoid of outside influences with prospective management of any potential conflicts.

There is no question that education, research, and development must be clearly differentiated and separated from sales and marketing activities in these relationships. The physician’s role in sales and marketing of a product should be carefully monitored and managed. PMAs have no direct role in sales and marketing. The presence of an exhibit area at a professional medical meeting should not be construed as any form of product endorsement by the PMA of the device, drugs or other product exhibited therein. A clear and publicly visible line should be drawn between device R&D and education versus sales and marketing. It is this area where much of the inappropriate behavior around product development has been identified. Surgical techniques have significantly changed in the past 20 years and will continue to evolve rapidly evolve in the foreseeable future. Clinicians are motivated primarily to find and employ optimal therapies for their patients; however, whenever there are rapid changes in new technology, the potential for financial abuse may arises whether due to the clinician’s enthusiasm for the new technology or the desire to be on the â€œcutting edge.â€ In a recent publication, Chatterji et.al. [6] pointed out that product development requires discovery, development, and dissemination. They noted that authors citing a particular device in medical journals have a great impact on the marketing and adoption of the device. It is estimated that one citation can increase the product’s market value by 3%, thus emphasizing the importance of ethical and fair guidelines for industry-physician relationships. In a widely publicized example, researchers published their experience with a new device to treat atrial fibrillation. The results with this device were remarkable and the company quickly saw its stock price rise. Unfortunately, the researchers had significant financial interests in the device and the company. This was not discovered until after publication, calling into question the credibility of the research and the device itself.

All of this speaks to the issue of disclosure and transparency. Postgraduate courses and scientific sessions must be constructed by physicians devoid of conflicting input from outside influences. Disclosure of any and all relationships between individual physicians or PMAs and industry must be fully declared and managed prior to presentation. As noted above, anything less is to conceal a potential influence that might bias opinions or decisions, especially when considering presenting or publishing experiences, making recommendations, or providing educational material. Complete disclosure of any industry relationship with industry is essential to avoid conflicts of interest, real or perceived. Anything less leaves us all at risk for confounding data, uncertainty in decisions about how we care for patients and erosion of the public trust.

In conclusion, the relationships between physicians or PMAs and industry are essential to the advancement of medical science. There are several examples where physicians and industry mismanaged these relationships due to personal and financial conflicts of interest, leaving no question that greater scrutiny and transparency are necessary to ensure established relationships remain appropriate and ultimately focused on improving patient care. However, to severely constrain and limit these interactions risks slowing or even halting medical progress, particularly for medical devices and procedures. All PMAs, medical institutions, and medical journals must establish and enforce conflict of interest guidelines that focus on differentiating R&D and education from sales and marketing, provide disclosure and transparency in all industry relationships, and require compliance by all their members. In addition, PMAs must require all officers and committee members to clearly identify any industry relationships and potential conflicts of interest. Publications in peer-reviewed journals must include a complete list of potential conflicts of interest from the authors. Continuing medical education literature must clearly identify speakers and resolve any potential conflicts of interest in advance of any content presented. By embracing these concerns, real or perceived, and taking active steps to manage conflict of interest and to provide complete transparency of physician relationships with industry, we can ensure preservation of public trust as well as these valuable relationships while minimizing regulatory over-infringement.

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Guidelines for clinical practice are intended to indicate preferable approaches to medical problems as established by experts in the field. These recommendations will be based on existing data or a consensus of expert opinion when little or no data are available. Guidelines are applicable to all physicians who address the clinical problem(s) without regard to specialty training or interests, and are intended to indicate the preferable, but not necessarily the only acceptable approaches due to the complexity of the healthcare environment. Guidelines are intended to be flexible. Given the wide range of specifics in any health care problem, the surgeon must always choose the course best suited to the individual patient and the variables in existence at the moment of decision.

Guidelines are developed under the auspices of the Society of American Gastrointestinal and Endoscopic Surgeons and its various committees, and approved by the Board of Governors. Each clinical practice guideline has been systematically researched, reviewed and revised by the guidelines committee, and reviewed by an appropriate multidisciplinary team. The recommendations are therefore considered valid at the time of its production based on the data available. Each guideline is scheduled for periodic review to allow incorporation of pertinent new developments in medical research knowledge, and practice.